K772216
Substantially EquivalentPORT-A-BOUT 240
- Applicant
- Hudson Oxygen Therapy Sales Co.
- Product code
- CAN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code CAN
product code CAN- Death
- 4
- Other
- 1
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.